510(k) · Cleared
ClearedRevitalair 430+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Hyperbaric Network · CBF Chamber, Hyperbaric
Cleared on May 4, 2023 as substantially equivalent to K171899 (Oxavita Srl, 2019) after a 457-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 4, 2023
- Review
- 457 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011312 (2001). 6 ancestors in all, the oldest K874752 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK011312 BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 2001
- 3 generations backK060739 Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006
- 2 generations backK072757 Dive and Shallow and Grand DiveSummit TO Sea · 2008
- 1 generation backK171899 Revitalair 430FOxavita Srl · 2019
- This deviceK220290 Revitalair 430+Us Hyperbaric Network · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011312 | BLKS-303 MK Monoplace Hyperbaric System | Khrunichev State Research & Production Space Centr | 2001 | — |
| −3 | K060739 | Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307 | Khrunichev State Research & Production Space Centr | 2006 | — |
| −2 | K072757 | Dive and Shallow and Grand Dive | Summit TO Sea | 2008 | — |
| −1 | K171899 | Revitalair 430F | Oxavita Srl | 2019 | — |
| 0 (this device) | K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBF device
- #1 K240569 FESL FINK Chamber; FEDL FINK Chamber; FETL…score 8.7 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171899 | Revitalair 430FSummary page 4…Anesthesiology Devices 3. Predicate Devices Predicate Devices: Primary Predicate: Revitalair 430F, K171899 Reference devices: Tampa Hyperbaric Monoplace Chamber, K981938… | 2019 |
| † | K981938 | Tampa Hyperbaric Monoplace Chamber | 1999 |
| † | K051759 | Flexi-Lite, Model FL-V1.2 | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBF
87in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBF
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBF
25in 2025
MAUDE reports naming product code CBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 3 | 134 | 2 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 87 | 0 | 11 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at health institutions and physician offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220290: Revitalair 430+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220290
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026